Federal Judges Don’t Want Surprises From Drug Patent Litigants

Access practice tools, as well as industry leading news, customizable alerts, dockets, and primary content, including a comprehensive collection of case law, dockets, and regulations. Leverage...

By Dana A. Elfin

Judges don’t like surprises.

A trio of federal district court judges said it is particularly critical for Hatch-Waxman litigants to resolve issues in advance because of the unique time pressure inherent in brand-generic drug patent litigation. They spoke at the American Conference Institute’s 11th Annual Paragraph IV Disputes conference in New York April 24.

Under the Hatch-Waxman Act, an automatic 30-month stay on regulatory approval is triggered when a branded drugmaker sues a generic drugmaker over its filing of an abbreviated new drug application (ANDA) seeking Food and Drug Administration approval to sell a generic version of the branded drug.

Hatch-Waxman Unique

“ANDA cases are unique in that we feel the time pressure for you, so to do things late in the process, it’s a big deal to us,” Judge Jose L. Linares of the U.S. Court for the District of New Jersey said. Linares will become chief judge of the court in May.

Because of the 30-month clock, Linares said, “We are trying to give ourselves 10 months to complete the case. We want time to review it, understand it and try to write something that makes sense.” If issues come up late in the game, “it puts me in a difficult situation to try to get the opinion out to you before the [30-month] stay runs out.”

For example, the judges said, litigants shouldn’t wait until the Markman patent claim construction hearing to amend their contentions. During a Markman hearing, parties argue their positions on how disputed patent claims in the case should be construed.

Amending Contentions Not Automatic Right

“The contentions need to mean something and advise the litigant of what’s being disputed,” Linares said.

“What information are you going to have in the Markman that you don’t have now?” he asked.

“It shouldn’t be an automatic right to amend your contentions based on Markman,” Judge Ruben Castillo of the U.S. District Court for the Northern District of Illinois said. “Good cause has to be shown.”

In the U.S. District Court for the Eastern District of Texas, litigants have 30 days after the Markman hearing to amend their contentions if there is a good faith basis to do so, the court’s Magistrate Judge Roy S. Payne said.

Deal With Problems Early

All the judges emphasized the importance of notifying the court of problems ahead of time.

For example, Linares said, if a lawyer sees something in an expert report that raises new issues that weren’t in the opposing party’s contentions the lawyer shouldn’t wait until trial to bring that to the court’s attention.

But the courts don’t have time to get pulled into the weeds of parties’ discovery disputes either, the judges said.

“You’re better off coming up with your own creative solutions to solve problems” rather than involving the court, Linares said. “Don’t fight over everything; it doesn’t make us more or less impressed with you.”

Live Expert Testimony Disfavored

The judges also weren’t big fans of allowing expert testimony in claim construction hearings.

“I still have not allowed live testimony from an expert in a Markman hearing,” Payne said. “Lawyers can cite me to the declarations of experts that are in the record. I don’t think it’s important enough to the issues to justify it becoming the main event.”

“You need to justify why you need to get hearing time,” Castillo said.

Linares said he’s more receptive to expert testimony if “there is an issue of fact in the case that’s going to inform the court and make the case a little easier.” But, even so, Linares said he limits the experts’ time and what they can address.

Limit Claims, Have Game Plan

Parties should limit their claims, the judges advised.

“The less we have to concentrate on, the better off you are,” Linares said. “Make sure the court understands which terms are more important than others.”

Litigants shouldn’t be afraid to reach agreement on issues and voluntarily limit claims ahead of time, he said.

“The more you can come and stipulate [agree on] what are the nonissues in the case, you’ll be better off with that judge,” Castillo agreed. “You need to have an efficient game plan that you can propose to us, and you need to make credible concessions on issues that are not going to be important.”

“In the Illinois rules, we have claim limitations, which have worked surprisingly well in these types of cases,” Castillo said. “We don’t have the time to be giving multiple hearings at multiple stages on different issues. We don’t have the luxury of time on our calendars,” he said.

Payne said some judges in his district have limited the number of claims parties can argue at a Markman hearing. “I have not imposed a limit, but I have come close to regretting that a number of times,” Payne said.

Don’t Ask for Summary Judgment

None of the judges was a fan of parties making partial summary judgment motions in ANDA cases. Summary judgment motions ask judges to resolve cases based on issues of law when there aren’t any disputed facts.

“We’re skeptical about it,” Castillo said, observing the U.S. District Court for the District of Delaware, which handles a large amount of ANDA cases, has “an almost ‘no summary judgment’ rule.”

“Generally speaking, don’t file a summary judgment motion unless it’s going to be case-dispositive,” Linares said. “And you’ve got to explain it to us.”

Stays Are Rare

Asking for a stay pending the resolution of a related action such as a proceeding at the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) was similarly disfavored.

“In the ANDA cases, the stay is a hard sell because of the timelines and the different [PTAB claim construction] standards,” Castillo said.

“Your chances of getting a stay goes back to if you can convince me that the parallel proceeding is very, very closely related to the issues in front of me,” Linares said. “But they never are,” he added.

Give Judges Road Map

The judges were fans of parties drafting proposed findings of fact before trial.

“I like proposed findings of fact because they send me in the right direction,” Linares said. “We want critical facts that the court will be called on to decide.”

Castillo said his court’s local rules require proposed findings of fact. “We’re trying to get to an efficient resolution,” he said.

Payne cautioned it is important to draft the proposed findings the right way. Don’t make them too general, Payne advised. “The judge is looking for what’s going to be a roadmap in the case,” he said. Litigants need to “let us know what evidence you’re going to be relying on.”

Barry P. Golob of Cozen O’Connor in Washington and Irena Royzman of Patterson Belknap Webb & Tyler LLP in New York moderated the panel.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.

Request Intellectual Property on Bloomberg Law